Condition category
Circulatory System
Date applied
04/04/2008
Date assigned
09/05/2008
Last edited
13/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lotscare.co.uk/

Contact information

Type

Scientific

Primary contact

Prof Anne Forster

ORCID ID

Contact details

Academic Unit of Elderly Care and Rehabilitation
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 383 406
a.forster@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RP-PG-0606-1128

Study information

Scientific title

Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care

Acronym

LoTS Care

Study hypothesis

The hypothesis for LoTS Care is that a system of care delivered by a Stroke Care Co-ordinator (SCC) to patients and carers living at home, in the community, will improve psychological and functional outcomes compared to usual SCC practice.

The primary objective of the trial is to determine whether the system of care improves psychological outcomes for patients requiring long term care at home.

The secondary objectives include:
1. Improved functional outcomes for patients requiring long-term support at home
2. Improved psychological and functional outcomes for carers of patients requiring long term support at home
3. Cost effectiveness

Ethics approval

Leeds (West) Research Ethics Committee, 09/05/2008, ref: 08/H1307/43

Study design

Pragmatic multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stroke

Intervention

Stroke services will be randomised into intervention or control groups using the stratification factors of quality of the stroke unit; referral rate and SCCs working alone versus within a community multidisciplinary team.

SCCs in stroke services randomised to the intervention group will be trained to deliver a system of care centered on key problems identified as of central importance to stroke patients and their carers. The assessment schedule is presented in a manual comprising 16 questions (patient) and 11 questions (carer) representing the identified problem areas, linked to reference guides containing educational text with algorithms of evidence based treatment options and associated patient carer action plans. Implementation of the assessment system is supported by a specific training programme.

SCCs in stroke services randomised to the control group will continue to deliver current community-based practice as determined by local policy and practice.

The SCC will undertake a primary assessment of patients (and carer if appropriate) using the system of care and instigate service responses, with additional follow-up and monitoring visits as appropriate to the needs of individual patients. Therefore there are no specified treatment times for either arms. Follow up of both the control and intervention arms of the patients (and carers if applicable) will be followed up at 6 and 12 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

General Health Questionnaire 12 (GHQ12) completed by the patient 6 months after recruitment

Secondary outcome measures

The secondary outcome measures for patients at 6 and 12 months are:
1. Frenchay Activities Index
2. Barthel Index
3. EQ-5D
4. Stroke Impact Scale
5. Longer-term Unmet Need in Stroke
6. Satisfaction
7. Death
8. Hospital re-admission
9. Institutionalisation
10. Total costs
11. Cost-effectiveness/cost-utility

The GHQ12 at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained.

The secondary outcome measures for carers at 6 and 12 months are:
1. GHQ12
2. Carer Burden Scale
3. Satisfaction
4. Death
5. Institutionalisation

Overall trial start date

01/06/2008

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

The trial is evaluating a complex intervention delivered by the Stroke Care Co-ordinator (SCC) within a stroke service and eligibility criteria apply at three levels - the stroke service, the stroke unit and the SCC.

A stroke service will only be considered for inclusion in the trial if it includes a stroke unit which fulfils the Royal College of Physicians guidelines definition of a stroke unit, that is, by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and carer organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff

Stroke Care Co-ordinators (SCC) will be eligible if they fulfill the following criteria:
1. A registered healthcare professional with documented experience in stroke care
2. Undertakes a community based liaison or co-ordinating role for stroke patients
3. Co-ordinates a range of longer-term care inputs on the patients' and carers' behalf (e.g., signposting, carrying out assessments)
4. Works within a stroke service as above

Patients with the following characteristics will be eligible for the trial:
1. Have a confirmed primary diagnosis of stroke
2. Are referred to a SCC on discharge home from hospital or within six weeks of stroke
3. Are still waiting for their first SCC assessment visit
4. Provide written informed consent or carer assent

All carers with the following characteristics are eligible for this study:
1. Identified by the patient
2. Eligible for this study
3. Provides the patient with practical support on at least a weekly basis

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

800 patients (and carers if applicable)

Participant exclusion criteria

Patients will be excluded from the trial if:
1. They are unlikely to survive for more than three months
2. Are being discharged to/resident in a nursing or residential home
3. Have been previously registered to the trial
4. They are taking part in other stroke research network adopted studies which involve 6- and 12-month follow-up questionnaires

Recruitment start date

01/06/2008

Recruitment end date

30/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Institute for Health Research
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

Bradford Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o John Wright
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364279
j.wright@bradfordhospitals.nhs.uk

Sponsor type

Government

Website

http://www.bradfordhospitals.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642527
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26152298

Publication citations

Additional files

Editorial Notes